Rising Number of Cases Reinforces the Need for Comprehensive Diagnostics

NEW YORK, Nov. 18, 2020 /PRNewswire/ -- Despite encouraging news from Moderna and Pfizer regarding the effectiveness of their vaccine candidates, it is still unclear when the pharmaceuticals will be ready to distribute the vaccines. In the meantime, the pandemic is expected to accelerate as winter approaches and the number of new cases is already rising sharply once again on the east coast. For example, in Massachusetts, new daily case numbers have crossed the 2,000 mark for the first time in six months. Virus-related hospitalizations have risen 46% since Sept. 23. The Boston Globe now reports that the mask mandate and limitations on gathering sizes ordered by Governor Baker could soon be followed by rolling back the state's reopening phases. Todos Medical Ltd. (OTC: TOMDF), Moderna, Inc. (NASDAQ: MRNA), Johnson & Johnson (NYSE: JNJ), BioNTech SE (NASDAQ: BNTX), Dynavax Technologies Corporation (NASDAQ: DVAX)

To properly combat the threat of the second wave and to avoid additional shut-downs, quality testing is among the top priorities for communities throughout the country. Anthony Fauci, the country's top infectious disease expert, said Tuesday he should have been more vocal about the importance of testing. "It never became a reality because we never really had enough tests to do the tests that you had to do," Fauci said Tuesday, according to a report by STAT. "Community spread doesn't stop spontaneously unless you do something about it… It is easier to stop when the level is relatively low. The only way that you can get at community spread is that you need to test people who are without symptoms, in order to show what the degree of penetrance of infection is."

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news that, "the completion of clinical validation and CLIA certification for MOTO+PARA's mobile lab. The Company's mobile CLIA lab partner, Integrated Health LLC, has fully validated the clinical performance of the proprietary COVID-19 RT-PCR laboratory testing process performed in MOTO+PARA's Mobile High Complexity Labs built to biosafety level 3 (BSL3), and has received the approval needed to begin offering COVID-19 screening and analysis as a service to clients anywhere in the United States. Rapid antigen and antibody testing also have been validated and are now ready to be deployed. MOTO+PARA is prepared to accept contracts from prospective clients immediately.

'We are thrilled to begin testing anywhere in the United States and worldwide with our first-of-their-kind mobile labs,' said Eric Canonico, CEO of MOTOPARA Foundation. 'With the recent surge of COVID-19 cases, the upcoming holidays predicted to further drive case counts, and the need to pair COVID-19 testing with other tests and emerging vaccination programs, our highly scalable mobile lab solutions are exactly what is needed to address the challenges COVID-19 has placed on existing testing infrastructure. MOTO+PARA is prepared to deploy rapid antigen and antibody tests in addition to diagnostic testing with our onsite RT-PCRs, which can turn results around in as little as 4 hours.'

'We are confident that the validations we have completed and the systems we have implemented will enable high scalability for our mobile labs,' said Jeff Faucheaux, CEO of Integrated Health. 'Being able to bring these all-encompassing COVID-19 testing solutions directly to the people will improve the end-to-end testing experience for the patient. This allows us to significantly reduce turnaround times for PCR testing and improve the value of each test we provide because the results will be available more quickly than with traditional lab methodologies.'

'The strategy of deploying all available testing solutions in the nation's first high complexity mobile labs allows us to assist MOTO+PARA in designing COVID-19 surveillance programs that will meet the diverse needs of different constituents who need access to testing for a myriad of use cases that have emerged since the pandemic began,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'Whether it is making highly sensitive PCR testing available to government entities with turnaround times fast enough to dramatically reduce infection risk, screening fans before entering a stadium for sporting events, or supporting disaster relief efforts to ensure emergency responders are working in a COVID-free environment, we believe these mobile labs are the solution to many of the nation's testing challenges. This distribution channel will also allow us to rapidly commercialize emerging novel COVID-19 lab-based testing and monitoring technologies we expect to come to market in the months ahead.'

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com "

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Moderna, Inc. (NASDAQ: MRNA) announced yesterday that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).

Johnson & Johnson (NYSE: JNJ) announced recently the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen's investigational COVID-19 vaccine candidate. Under the amendment, Janssen will commit approximately USD 604 Million and BARDA will commit approximately USD 454 Million to support the ongoing Phase 3 ENSEMBLE trial evaluating Janssen's investigational COVID-19 vaccine candidate as a single-dose in up to 60,000 volunteers worldwide. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "We greatly value the ongoing confidence and support of our investigational COVID-19 vaccine candidate development program. Combined with our own significant investment, this agreement has enabled our vital research and development and underscores the importance of public-private partnerships to tackle the worldwide COVID-19 pandemic."

BioNTech SE (NASDAQ: BNTX) together with Pfizer announced last week that they have reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to European Union (EU) Member States, with an option for the European Commission to request an additional 100 million doses. Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization. Vaccine doses for Europe will be produced in BioNTech's German manufacturing sites, as well as in Pfizer's manufacturing site in Belgium. If the BNT162b2 vaccine candidate receives approval from the European Medicines Agency (EMA), then the European Commission will lead the process for allocation of the vaccine doses among the EU Member States who have elected to receive the vaccine as part of this agreement.

Dynavax Technologies Corporation (NASDAQ: DVAX) reported ack in August a grant from the Bill & Melinda Gates Foundation of USD 3.4 Million to scale up production batch size to allow for increased capacity of Dynavax's CpG 1018 advanced adjuvant to support the global COVID-19 response. These efforts will support capacity of up to 750 million adjuvant doses annually, which can be further increased if needed. "We are honored to receive this funding from the Bill & Melinda Gates Foundation to support development of a much-needed vaccine for COVID-19. This grant facilitates scale up of production capacity to ensure the availability of CpG 1018 for collaboration partners developing adjuvanted vaccines for COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We believe adjuvants will play an important role in developing effective vaccines for COVID-19, including for those patients at greatest risk for severe disease. The ability of CpG 1018 to potentially provide an improved immune response and also reduce the amount of vaccine antigen necessary will help provide more vaccine doses to meet the global need."

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